Description

The impact of Data Integri
ty issues on a regulated company can be significant: it can result in reca
lls of products\, warning or untitled letters\, import alerts\, injunction
s\, seizures\, legal action\, etc. These regulatory actions can have signi
ficant financial impact to the company. However\, and most importantly\, d
ata integrity issues can lead to potential patient harm!!

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Defined by the Medicines and Healthcare Pro
ducts Regulatory Agency (MHRA) as &quot\;the extent which all data are com
plete\, consistent and accurate throughout the data lifecycle&quot\;\, dat
a integrity is increasingly the focus of regulatory agencies round the wor
ld. Companies must now ensure that they are appropriately addressing data
integrity and data governance. This includes organizational\, procedural a
nd technical controls that must be considered as part of an overarching da
ta governance system. In addition\, the effort and resources committed to
data integrity must be commensurate with the role it plays in assuring pro
duct quality.

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To ensure Dat
a Integrity\, a GxP regulated company needs to abide by principles\, curre
nt regulations and industry best practices on the expectations for the man
agement GxP regulated records and data. These principles\, regulations and
best practices\, ensure that data is complete\, consistent\, accurate\, s
ecure and available throughout the record life cycle. This approach is int
ended to encourage innovation and technological advances while avoiding un
acceptable risk to product quality\, patient safety and public health.

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Key implementation considerati
ons for a corporate data integrity program\, include development of a high
-level strategy\, identifying and gaining executive sponsorship\, focusing
on management accountability\, implementing tools for knowledge sharing a
nd developing and providing the appropriate levels of training. An effecti
ve data integrity program includes addressing of behavioral factors and dr
ives a strategy that focuses on prevention\, detection\, response and cont
inuous improvement.

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The Seminar:

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This Semina
r addresses the integrity of GxP records and data used within the regulate
d industries including pharmaceutical\, biological\, medical devices\, cos
metics\, food and any other industry where data integrity is important. It
provides a method for managing risk to record and data integrity. Learnin
g Objectives for the seminar include: